Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F— 510(k) K203067

Substantially Equivalent

Qura S.R.L

FDA 510(k) clearance K203067 for Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Substantially Equivalent on 2021-11-08. Applicant: Qura S.R.L.

Clearance details

Applicant: Qura S.R.L
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2020-10-09
Decision date: 2021-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.